EducationPhase 1NCT00425295
Effectiveness of Human Simulation Training for Medical Crisis Management Skills
A Phase 1 study testing Human Simulation Training in people with Education, run by University of Pittsburgh at 1 site in United States.
Trial summary
The main purpose of this study is to assess the effectiveness of human simulation in the training of the leadership, cognitive, and psychomotor skills required to lead medical crisis management teams. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Education
- What is being tested?
- Human Simulation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All consenting adult critical care medicine trainees at the MCCTP
Who cannot join
- Academic probation within training program
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center, Presbyterian Hospital
Pittsburgh, Pennsylvania, 15261
About this study
The main purpose of this study is to assess the effectiveness of human simulation in the training of the leadership, cognitive, and psychomotor skills required to lead medical crisis management teams. All participants in the study are trainees in the University of Pittsburgh Medical Center (UPMC) Multi-Disciplinary Critical Care Training Program (MCCTP.) All trainees will have received the standard critical care medicine-training curriculum including basic airway management, management of hypotension, unstable cardiac arrhythmias, difficult airway management and crisis team training. The participants will have also completed six months of baseline clinical training, which includes responding to medical emergencies at UPMC.
The specific aims of this study are:
- To assess the effectiveness of Human Simulation Training (HST) as an educational tool for teaching medical crisis management.
- To determine the effect of HST on objective measures of performance in the domains of communication, leadership, cognition and psychomotor skills.
Read the detailed description
The use of Medical Emergency Teams (METS) for handling in-hospital medical crisis decreases mortality and improves patient safety. Adverse in-hospital events occur in about 4-17% of hospital admissions. Of these, 70% are thought to be preventable. The most serious adverse in-hospital event is unexpected cardiac arrest which carries a mortality rate of 50-80% [1]. One approach to reducing this adverse event is the use of METS. Unlike traditional cardiopulmonary resuscitation teams, which respond to cardiac arrests, METS respond to medical crises early on and aim to prevent the progression of problems into unstable situations. The implementation of METS have been found to decrease the number of unexpected cardiac arrests, intensive care unit transfers and in-hospital mortality [1]. Bellomo et al. further found that the implementation of a MET not only decreases hospital mortality but also decreases incidence of post-operative complications [2]. As an integral part of the MET, a critical care physician must have the communication and leadership skills to effectively manage the team, the cognitive skills to adequately assess/judge the situation and guide plan of actions, and the psychomotor skills to perform necessary procedures.
Existing methods for teaching medical crisis management are inadequate. The instruction of medical trainees in the management of acute medical crisis is often done through didactic teaching, problem based learning, and apprenticeship. It is not uncommon for a trainee's first experience managing medical crisis to be on a real patient who is experiencing a real medical crisis with significant consequences. This form of training is limited and clearly sub-optimal for many reasons. Didactic training and problem based learning may be useful in instilling medical knowledge but is often inadequate in teaching the communication skills and critical thinking that is involved in managing medical crises. Further, the urgency and complexity of medical crisis is not well understood without first-hand experience. In general, although medical crises are relatively common, trainees get limited opportunities for the repetition required to hone their management skills. Some medical crises, such as respiratory distress with difficult airway, are extremely rare and will not often be experienced by most trainees. Moreover, when they do occur, trainees may not have enough supervision and hence do not receive appropriate feedback. Thirdly, clinical apprenticeship does not provide for standardization of training and feedback for the trainees. Lastly, most trainees are not allowed to view the consequences of the errors made while managing medical crises as most supervisors will intervene to prevent patient injury or harm [3-6].
HST can be used as an educational tool for teaching medical crisis management. Simulation training has been used in other fields, such as aviation and the military, to train people to do complex tasks with potentially dangerous consequences [7-13]. A curriculum using HST may be a useful at surpassing some of the limitations of traditional training noted above[14]. The full body human simulator such as Laerdal's Sim Man, can be programmed to present a wide range of physiologic conditions and physical exam findings. Using this human simulator, a wide variety of medical crises can be programmed to recreate real-life situations. The human simulator also allows the re-creation of clinically important but rare situations. The human simulator will also allow trainees to manage medical crises repetitively until a satisfactory level of proficiency can be reached.
Most importantly, HST allows trainees to repetitively experience dangerous situations and practice their crisis management skills. Trainees can now benefit by seeing their management errors run their course without placing patients at risk. HST allows for providing immediate feedback. This technology is portable and hence allows for trainees from various institutions within a particular region to have standardized training and feedback. The 1999 Institute of Medicine Report, "To Err is Human," challenged the medical community to confront the issue of medical error. One innovative approach that was mentioned for performance improvement and healthcare training was the use of human simulators [15].
Human Simulators are a valuable and valid performance evaluation tool. Human simulators have long been used in the field of medicine for evaluation. In particular, the field of anesthesia has taken the lead in terms of using advanced full body simulators for resident and physician training and evaluation. Instructors in the field of anesthesia have used human simulators to re-create dangerous and complex intra-operative crises to help their trainees acquire, test, and practice skills of crisis resource management without placing patients at risk [16-18]. By using evaluation techniques such as videotaped review and checklists, anesthesia instructors have been able to assess the behavioral and technical performances of trainees[18-21].
The effectiveness of HST as a training tool in medical crisis management needs to be explored.
Due to the success of human simulation as an educational tool for anesthesia crisis, HST is now being used as a tool for training medical emergency teams for dealing with medical crisis. Lighthall et al. has showed that HST can be used to teach crisis management to internal medicine residents[22]. This study showed that the majority of participants felt that simulator training had an educational value, but did not quantify their performance of technical and non-technical skills. DeVita et al. looked at the effect of HST on improving crisis team skills. This study found that repeated experience using the simulator with immediate feedback improved team performance in terms of correctly completing the steps necessary for patient/simulator survival[23]. There are no studies, which look at whether HST improves crisis management skills in a randomized study design.
2.2 Significance The field of simulation education is highly evolved in other high-risk industries such as aviation and nuclear power plants. Its time is coming in medical education, particularly with the emerging emphasis on improved patient safety. Proven and practical outcome based educational programs are needed to support the cultural changes necessary to influence the changes in fields of education in clinically relevant domains such as medical crisis resource management.
Medical crisis management skills are essential to the function of METS. HST is a useful tool that can safely re-create medical crises to teach and evaluate trainees in these skills. Although HST has been widely studied in anesthesia crisis management, there are no studies that look at the effect of HST on medical crisis management skills. We feel that this study will help to determine what effect if any, HST has on the communication, leadership, cognitive and psychomotor skill level needed to be effective at medical crisis management.
The participants for this prospective, blinded, randomized cross over trial will be consenting critical care trainees from the MCCTP at UPMC(Appendix 1 for consent forms). All participants will have similar baseline education in basic airway management, management of cardiovascular emergencies, and difficult airway management before testing occurs. Further, each participant will have similar clinical experience as a critical care trainee participating in METS at UPMC.
Each participant will undergo baseline testing using HST . Using 4 simulated clinical scenarios using the human simulator will test each participant. Participants will then be randomized into two groups. Control group (A) will receive no further training, while the intervention group ( B) will receive HST curriculum for medical crisis management. The groups will then be tested again after an interval of 1 month using 4 different simulated clinical scenarios. The groups will then be crossed over. The original control group (A) will now receive HST and the original intervention group ( B) will receive no further training. These two groups will again be tested using a third new set of simulated clinical scenarios. This study design is summarized in Appendix 2.
Both testing and the intervention will occur at the Peter Winter Institute for Simulation, Education and Research (WISER Center). All instructors and evaluators will be critical care faculty or senior fellows who have undergone training at WISER and are familiar with simulation teaching and evaluation.
The four medical crisis scenarios used for testing are designed to represent the most common medical crises experienced at UPMC. Each scenario will be programmed into the Laerdal SimMan human simulator. The basic physiologic problem and expected responses will be the same for all participants and all phases of testing; however, the scripted presentation will be varied to prevent pattern recognition. Participant performance will be evaluated using a checklist of expected actions as determined by the investigators. Each item will represent a communication skill, cognitive skill or a psychomotor skill. A total score as well as domain specific scores will be recorded at the end of each testing session for each participant. Blinded evaluators will perform all evaluations.
The intervention for this study will be a HST Curriculum. The curriculum will consist of two parts. One is a didactic review of crisis management principles. The second part is a simulation-based curriculum consisting of two scenarios. Each participant will undergo both scenarios and receive immediate feedback regarding their communication, cognitive and psychomotor performance.
- Conditions
- Education
- Being tested
- Human Simulation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Simulation TrainingBehavioural
Fellows will undergo Human Simulation Training (HST) composed of one 1 hour session of high-fidelity simulation of crisis scenarios requiring management of critical care skills, including triage, Advanced Cardiac Life Support (ACLS), team management, and difficult airway management.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Behavioral: Human Simulation Training |
| 2 | Experimental | Not described Receives: Behavioral: Human Simulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of Human Simulation Training (HST) as an educational tool for teaching medical crisis management through objective measures of performance in the domains of communication, leadership, cognition and psychomotor skills.
Measured: 6 week intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: too much cross over bias between small numbers of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lillian Emlet, University of Pittsburgh
- Investigators
- Ramesh Venkataraman, MD, Principal investigator, Department of Critical Care Mediine, University of Pittsburgh Medical CenterLillian L Emlet, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425295
- Sponsor's protocol ID
- 0501050
- Status last verified
- Dec 2014
- First submitted
- 19 Jan 2007
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Human Simulation Training for Medical Crisis Management Skills
- ClinicalTrials.gov ID
- NCT00425295
- Acronym / sponsor ID
- 0501050
- Conditions
- Education
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: too much cross over bias between small numbers of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the effectiveness of human simulation in the training of the leadership, cognitive, and psychomotor skills required to lead medical crisis management teams. All participants in the study are trainees in the University of Pittsburgh Medical Center (UPMC) Multi-Disciplinary Critical Care Training Program (MCCTP.) All trainees will have received the standard critical care medicine-training curriculum including basic airway management, management of hypotension, unstable cardiac arrhythmias, difficult airway management and crisis team training. The participants will have also completed six months of baseline clinical training, which includes responding to medical emergencies at UPMC.
The specific aims of this study are:
- To assess the effectiveness of Human Simulation Training (HST) as an educational tool for teaching medical crisis management.
- To determine the effect of HST on objective measures of performance in the domains of communication, leadership, cognition and psychomotor skills.
Detailed description
The use of Medical Emergency Teams (METS) for handling in-hospital medical crisis decreases mortality and improves patient safety. Adverse in-hospital events occur in about 4-17% of hospital admissions. Of these, 70% are thought to be preventable. The most serious adverse in-hospital event is unexpected cardiac arrest which carries a mortality rate of 50-80% [1]. One approach to reducing this adverse event is the use of METS. Unlike traditional cardiopulmonary resuscitation teams, which respond to cardiac arrests, METS respond to medical crises early on and aim to prevent the progression of problems into unstable situations. The implementation of METS have been found to decrease the number of unexpected cardiac arrests, intensive care unit transfers and in-hospital mortality [1]. Bellomo et al. further found that the implementation of a MET not only decreases hospital mortality but also decreases incidence of post-operative complications [2]. As an integral part of the MET, a critical care physician must have the communication and leadership skills to effectively manage the team, the cognitive skills to adequately assess/judge the situation and guide plan of actions, and the psychomotor skills to perform necessary procedures.
Existing methods for teaching medical crisis management are inadequate. The instruction of medical trainees in the management of acute medical crisis is often done through didactic teaching, problem based learning, and apprenticeship. It is not uncommon for a trainee's first experience managing medical crisis to be on a real patient who is experiencing a real medical crisis with significant consequences. This form of training is limited and clearly sub-optimal for many reasons. Didactic training and problem based learning may be useful in instilling medical knowledge but is often inadequate in teaching the communication skills and critical thinking that is involved in managing medical crises. Further, the urgency and complexity of medical crisis is not well understood without first-hand experience. In general, although medical crises are relatively common, trainees get limited opportunities for the repetition required to hone their management skills. Some medical crises, such as respiratory distress with difficult airway, are extremely rare and will not often be experienced by most trainees. Moreover, when they do occur, trainees may not have enough supervision and hence do not receive appropriate feedback. Thirdly, clinical apprenticeship does not provide for standardization of training and feedback for the trainees. Lastly, most trainees are not allowed to view the consequences of the errors made while managing medical crises as most supervisors will intervene to prevent patient injury or harm [3-6].
HST can be used as an educational tool for teaching medical crisis management. Simulation training has been used in other fields, such as aviation and the military, to train people to do complex tasks with potentially dangerous consequences [7-13]. A curriculum using HST may be a useful at surpassing some of the limitations of traditional training noted above[14]. The full body human simulator such as Laerdal's Sim Man, can be programmed to present a wide range of physiologic conditions and physical exam findings. Using this human simulator, a wide variety of medical crises can be programmed to recreate real-life situations. The human simulator also allows the re-creation of clinically important but rare situations. The human simulator will also allow trainees to manage medical crises repetitively until a satisfactory level of proficiency can be reached.
Most importantly, HST allows trainees to repetitively experience dangerous situations and practice their crisis management skills. Trainees can now benefit by seeing their management errors run their course without placing patients at risk. HST allows for providing immediate feedback. This technology is portable and hence allows for trainees from various institutions within a particular region to have standardized training and feedback. The 1999 Institute of Medicine Report, "To Err is Human," challenged the medical community to confront the issue of medical error. One innovative approach that was mentioned for performance improvement and healthcare training was the use of human simulators [15].
Human Simulators are a valuable and valid performance evaluation tool. Human simulators have long been used in the field of medicine for evaluation. In particular, the field of anesthesia has taken the lead in terms of using advanced full body simulators for resident and physician training and evaluation. Instructors in the field of anesthesia have used human simulators to re-create dangerous and complex intra-operative crises to help their trainees acquire, test, and practice skills of crisis resource management without placing patients at risk [16-18]. By using evaluation techniques such as videotaped review and checklists, anesthesia instructors have been able to assess the behavioral and technical performances of trainees[18-21].
The effectiveness of HST as a training tool in medical crisis management needs to be explored.
Due to the success of human simulation as an educational tool for anesthesia crisis, HST is now being used as a tool for training medical emergency teams for dealing with medical crisis. Lighthall et al. has showed that HST can be used to teach crisis management to internal medicine residents[22]. This study showed that the majority of participants felt that simulator training had an educational value, but did not quantify their performance of technical and non-technical skills. DeVita et al. looked at the effect of HST on improving crisis team skills. This study found that repeated experience using the simulator with immediate feedback improved team performance in terms of correctly completing the steps necessary for patient/simulator survival[23]. There are no studies, which look at whether HST improves crisis management skills in a randomized study design.
2.2 Significance The field of simulation education is highly evolved in other high-risk industries such as aviation and nuclear power plants. Its time is coming in medical education, particularly with the emerging emphasis on improved patient safety. Proven and practical outcome based educational programs are needed to support the cultural changes necessary to influence the changes in fields of education in clinically relevant domains such as medical crisis resource management.
Medical crisis management skills are essential to the function of METS. HST is a useful tool that can safely re-create medical crises to teach and evaluate trainees in these skills. Although HST has been widely studied in anesthesia crisis management, there are no studies that look at the effect of HST on medical crisis management skills. We feel that this study will help to determine what effect if any, HST has on the communication, leadership, cognitive and psychomotor skill level needed to be effective at medical crisis management.
The participants for this prospective, blinded, randomized cross over trial will be consenting critical care trainees from the MCCTP at UPMC(Appendix 1 for consent forms). All participants will have similar baseline education in basic airway management, management of cardiovascular emergencies, and difficult airway management before testing occurs. Further, each participant will have similar clinical experience as a critical care trainee participating in METS at UPMC.
Each participant will undergo baseline testing using HST . Using 4 simulated clinical scenarios using the human simulator will test each participant. Participants will then be randomized into two groups. Control group (A) will receive no further training, while the intervention group ( B) will receive HST curriculum for medical crisis management. The groups will then be tested again after an interval of 1 month using 4 different simulated clinical scenarios. The groups will then be crossed over. The original control group (A) will now receive HST and the original intervention group ( B) will receive no further training. These two groups will again be tested using a third new set of simulated clinical scenarios. This study design is summarized in Appendix 2.
Both testing and the intervention will occur at the Peter Winter Institute for Simulation, Education and Research (WISER Center). All instructors and evaluators will be critical care faculty or senior fellows who have undergone training at WISER and are familiar with simulation teaching and evaluation.
The four medical crisis scenarios used for testing are designed to represent the most common medical crises experienced at UPMC. Each scenario will be programmed into the Laerdal SimMan human simulator. The basic physiologic problem and expected responses will be the same for all participants and all phases of testing; however, the scripted presentation will be varied to prevent pattern recognition. Participant performance will be evaluated using a checklist of expected actions as determined by the investigators. Each item will represent a communication skill, cognitive skill or a psychomotor skill. A total score as well as domain specific scores will be recorded at the end of each testing session for each participant. Blinded evaluators will perform all evaluations.
The intervention for this study will be a HST Curriculum. The curriculum will consist of two parts. One is a didactic review of crisis management principles. The second part is a simulation-based curriculum consisting of two scenarios. Each participant will undergo both scenarios and receive immediate feedback regarding their communication, cognitive and psychomotor performance.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Human Simulation Training |
| 2 | Experimental | Behavioral: Human Simulation Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consenting adult critical care medicine trainees at the MCCTP
Key exclusion criteria (1 listed)
- Academic probation within training program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Simulation TrainingFellows will undergo Human Simulation Training (HST) composed of one 1 hour session of high-fidelity simulation of crisis scenarios requiring management of critical care skills, including triage, Advanced Cardiac Life Support (ACLS), team management, and difficult airway management. | Behavioural | 1, 2 |
Primary outcome
To assess the effectiveness of Human Simulation Training (HST) as an educational tool for teaching medical crisis management through objective measures of performance in the domains of communication, leadership, cognition and psychomotor skills.
Time frame: 6 week intervals.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramesh Venkataraman, MD principal investigator
Department of Critical Care Mediine, University of Pittsburgh Medical Center
Lillian L Emlet, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human Simulation Training in people with Education, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of Human Simulation Training (HST) as an educational tool for teaching medical crisis management through objective measures of performance in the domains of communication, leadership, cognition and psychomotor skills. (time frame: 6 week intervals.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.